Kronos Early Estrogen Prevention Study (KEEPS)

PHASE4UnknownINTERVENTIONAL
Enrollment

728

Participants

Timeline

Start Date

September 30, 2005

Primary Completion Date

May 31, 2012

Study Completion Date

July 31, 2012

Conditions
MenopauseArteriosclerosis
Interventions
DRUG

Conjugated equine estrogens 0.45 mg/day

Pill, 1 pill taken daily each month for the study duration

DRUG

Transdermal estradiol, 50 mcg/day

Patch; 1 patch is applied to the skin weekly. Patch site is rotated on a weekly basis.

DRUG

Micronized progesterone, 200 mg/day x 12 d/month

capsule, 1 capsule taken daily for the first 12 days of each month for the study duration

DRUG

CEE , progesterone, estradiol patch or placebo for each

CEE 0.45mg 1 PO QD Progesterone 200 mg 1 PO HS first 12 days of the month estradiol patch use 1 per week

DRUG

CEE, progesterone, transdermal patch or the placebo

CEE 0.45 mg 1 PO QD or placebo equivalent Prometrium 200 mg 1 PO qHS for first 12 dasy of each month or placebo equivalent transdermal patch 0.05 mg use 1 patch per week or placebo equivalent

Trial Locations (9)

10032

Columbia Presbyterian Hospital, New York

10461

Albert Einstein College of Medicine, The Bronx

55905

Mayo Clinic, Rochester

84108

University of Utah, Salt Lake City

94115

University of California, San Francisco, San Francisco

98493

University of Washington/VA Puget Sound, HCS, Seattle/Tacoma

85016-3452

Kronos Longevity Research Institute, Phoenix

06519

Yale University Medical Center, New Haven

02215

Brigham and Women's Hospital, Boston

Sponsors
All Listed Sponsors
collaborator

Albert Einstein College of Medicine

OTHER

collaborator

Brigham and Women's Hospital

OTHER

collaborator

Columbia University

OTHER

collaborator

Mayo Clinic

OTHER

collaborator

University of California, San Francisco

OTHER

collaborator

University of Utah

OTHER

collaborator

University of Washington

OTHER

collaborator

Yale University

OTHER

lead

Kronos Longevity Research Institute

OTHER